Identity
- Trade Name
- VFE FDA UDI
- Generic Name
- Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
- Device Name
- EIA-VON WILLEBR. FDA UDI
- Model / Reference
- VE-98 FDA UDI
- Description
- EIA-VON WILLEBR. FDA UDI
Identifiers
- Catalog Number
- VE-98 FDA UDI
- Primary DI / UDI-DI
- 08600000686048 FDA UDI
- 510(k) Number
- K983107 FDA UDI
- FDA Product Code
- GGP FDA UDI
- GMDN Term
- Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA) FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 864.7290 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA)
Vfe by Ramco Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Coagulation factor VIII-associated antigen IVD, kit, enzyme immunoassay (EIA).
- Asserachrom® VWF:Ag — DIAGNOSTICA STAGO, INC. · Class II
- von Willebrand Factor Antigen ELISA Kit (96 tests) — Helena Laboratories, Corp. · Class II
- REAADS von Willebrand Factor Antigen Test Kit — CORGENIX MEDICAL CORPORATION · Class II
- Rocket Stain — Helena Laboratories, Corp. · Class II
- von Willebrand Factor Antigen Rocket Kit — Helena Laboratories, Corp. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Ramco Laboratories, Inc.
Sources (1)
- FDA UDI f15f14a2-6149-4452-ae91-f76b6cc8145f 36 fields · synced May 30, 2026